Transcranial stimulation device and method based on electrophysiological testing

ABSTRACT

Embodiments of the disclosed technology provide a combination electroencephalography and non-invasive stimulation devices. Upon measuring an electrical anomaly in a region of a brain, various tDCS or other electrical stimulations are utilized to correct neural activity. Devices of the disclosed technology may utilize visual, balance, auditory, and other stimuli to test the subject, analyze necessary brain stimulations, and administer stimulation to the brain.

FIELD OF THE DISCLOSED TECHNOLOGY

The disclosed technology relates generally to the assessment andremediation of abnormal brain and physiological functioning. Morespecifically, the technology relates to assessing and localizingabnormal brain functioning and heart rate function as well as theconcomitant physical dysfunctions that may result.

BACKGROUND OF THE DISCLOSED TECHNOLOGY

Traumatic brain injuries can result in physical and/or emotionaldysfunction. Post traumatic stress disorder (PTSD) symptoms are similarto those of a mild traumatic brain injury (mTBI) and the two aredifficult to differentiate using current assessment methodologies suchas symptom assessments and questionnaires. In Army deployment,statistics have shown that upwards of 20% of soldiers suffer from mildtraumatic brain injury (mTBI). Head and neck injuries, including severebrain trauma, have been reported in one quarter of United States servicemembers who have been evacuated from Iraq and Afghanistan in the firstdecade of the 21^(st) century. A common cause of such injuries arisesfrom exposure to percussive force from explosive devices. Further,recent military analysis indicates that over 90% of patients with acutemTBI will have vestibular (inner ear balance) disorders and thosevestibular disorders are present in over 80% of persons with chronicmTBI symptoms. Likewise, stress disorders further affect numerousindividuals, whether in a military or civilian situation. Brain injuriesmay further be incurred from car and bicycle accidents, sportsaccidents, falls, and the like. Up to 15% of persons suffering even amild brain injury, or concussion, will suffer from persistent symptomsfor more than a year, which significantly negatively affect theirability to work and function in daily life. It is estimated that thereare currently 5.3 million Americans living with a disability as a resultof a TBI. There are approximately 1.5 million diagnosed brain injuriesin the U.S. annually, and it is estimated that another 2 million TBIsoccur but are not properly diagnosed. Current assessment methods areeither prohibitively expensive or do not diagnose the root cause of thesuffering. Thus, there is a need in the art to accurately and quicklyassess brain injury and associated dysfunction and then find ways to aidor enhance optimal functioning.

The brain is composed of about 100 billion neurons, more than 100billion support cells and between 100 and 500 trillion neuralconnections. Each neuron, support cell and neural connection isextremely delicate, and the neural connections are tiny (approximately 1micrometer). When the brain moves within the skull, such as occurs inrapid acceleration/deceleration (e.g., exposure to sudden impact and/orexplosive devices), axons within the brain can pull, stretch and tear.If there is sufficient injury to the axon or support cells, the cellwill die, either immediately or within a few days. Such damage can occurnot only in the region that suffered direct trauma but in multipleregions (e.g., diffuse axonal injury). Loss of consciousness is not aprerequisite for mild traumatic brain injury and occurs in less than 5%of mild brain injuries, and head injuries such as diffuse axonal injuryare not detectable in routine CT or MRI scan. High false negativefindings may lead to patients being undiagnosed or misdiagnosed.Unfortunately current imaging methods still lack the resolution andsensitivity to determine functional brain capacity. Rating scales andother neuropsychological and functional examination methods have longbeen used to elucidate these functional questions, but they too arefraught with false negative results and limited specificity.

With the high prevalence of age-related cognitive decline conditions,injury from falls, cerebral-vascular events, neurodegenerativeconditions (i.e., Alzheimer's Disease) and the many brain injuriesoccurring in sports and in military operation theaters, there is a needfor a rapid and portable assessment instrument that can identify mTBIand neurocognitive dysfunction (e.g., balance, processing speed), directand provide treatment interventions, track recovery progress, and aid inpeak performance or the determination of return to leisure activities orduty.

SUMMARY OF THE DISCLOSED TECHNOLOGY

An object of the disclosed technology is to utilize a brain-computerinterface with electroencephalography and event-related potential (ERP)measures to localize brain injury and dysfunctional regions.

A further object of the disclosed technology is to provide low intensitydirect current stimulation to dysfunctional brain regions as directed bythe result(s) of electroencephalography (EEG) and event-relatedpotential (ERP) measures.

Yet another object of the disclosed technology is to providetranscranial direct current stimulation (tDCS) for selectivestimulation, based on measures of brain activity and physiologicalcharacteristics and measures.

In a method of the disclosed technology, electrophysiological datarecording and analysis, with manual or automated delivery oftranscranial direct current stimulation proceeds as follows. Via atleast one electrode and at least one reference and ground electrode and,in embodiments, a plurality of electrodes, non-invasive measurements ofelectrical currents produced by the brain of a person are conducted.This is done while directed stimuli, such as auditory or visual stimulior balance tasks (for the purpose of examining brain reactions andprocessing of stimuli) are administered to the person being tested. Abrain functional abnormality in the person, based on the conducting andthe measuring, is determined. As a result of analysis of the brainelectrical activity at rest and reactions and processing of stimuli,non-invasive brain stimulation takes place via said at least one anodeelectrode and said at least one cathode electrode to said brain of saidperson.

In embodiments of the above, a single electrode is surrounded by atleast three electrodes. When the electrodes are used for stimulationpurposes, the surrounding electrodes are of opposite polarity in acluster. That is, an anode may be surrounded by three cathodes or acathode may be surrounded three anodes. A plurality of such clusters maybe utilized, such as by pre-placement in a helmet. Each cluster, or anysingle or plurality of electrodes, may be used to simultaneously oralternately stimulate different regions of the brain, based on theanalysis described above.

The above-described analysis is augmented, in embodiments of thedisclosed technology, based additionally on at least one additionalmeasured/augmented physiological characteristic of a person. Such anadditional measured/augmented physiological characteristic may be heartrate variability, a measure of balance, and measures of cognitive/peakperformance, and pathology comparisons.

The conducting of non-invasive measurement of electrical currents, aswell as the non-invasive brain stimulation, may be carried out by way ofa single device with a single manually-operated control. Or, the controlmay be pre-configured and automated. That is, electric current in thebrain may be measured, an anomaly discovered, and a pre-programmednon-invasive stimulation is then carried out in the same portion of thebrain as the anomaly, and, in embodiments, using the same electrode orelectrodes to stimulate as were used to measure.

In a system of embodiments of the disclosed technology, a joint brainelectro-analysis and transcranial direct current stimulation system ismade up of a plurality of spaced-apart removable and replaceableelectrodes arranged in a piece of headgear, an electroencephalographydevice wired to each of the electrodes, and a transcranial directcurrent stimulation device wired to each of the electrodes. In thissystem, upon measuring an electroencephalography anomaly in a brainregion with the electroencephalography device, transcranial directcurrent stimulation is engaged to at least one anode and at least onecathode electrode of the brain region where the anomaly was measured.

An additional (distinct and separate) device may be used for measuringphysiological characteristics of a person wearing the piece of headgear.Such an additional device may measure heart rate variability, balance,cognitive impairment, and/or make pathology comparisons.

The electroencephalography device and the transcranial direct currentstimulation device may be contained within a single housing, may beoperable with a single set of controls, or may consist of separatedevices requiring manual disconnection of a wire hub to the electrodes,and connection to the other device.

In accordance with these and other objects, which will become apparenthereinafter, the disclosed technology will now be described withparticular reference to the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a high level drawing of a device used to carry outembodiments of the disclosed technology.

FIG. 2 shows a high level block diagram of a method of carrying outembodiments of the disclosed technology.

FIG. 3 shows an example of a test used to measure psychologicalcharacteristics of a test subject.

FIG. 4 shows a perspective view of a helmet with electrodes used inembodiments of the disclosed technology.

FIG. 5 shows a bottom view of a helmet with electrodes used inembodiments of the disclosed technology.

FIG. 6 shows electrical pathways to electrodes within a helmet of anembodiment of the disclosed technology.

FIG. 7 is a side view of an electrode with disposable electrode bootattachment used in an embodiment of the disclosed technology.

FIG. 8 is a high-level block diagram of a bidirectional transceiver thatmay be used to carry out the disclosed technology.

A better understanding of the disclosed technology will be obtained fromthe following detailed description of the preferred embodiments taken inconjunction with the drawings and the attached claims.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE DISCLOSED TECHNOLOGY

Embodiments of the disclosed technology comprise systems and methods forassessing and repairing neurological pathways damaged by trauma or otherbrain-related dysfunction. The methods comprise training a patient andstimulating brain areas where a functional abnormality (such as abnormalelectrical activity outside a threshold of voltage, regularity,coherence, phase, and/or rate) has been detected. Such functionalabnormalities are determined based on electroencephalography testing, aphysiological test that passively monitors electrical current of atleast one electrode positioned over the head of a test subject.

Systems of the disclosed technology comprise the use of anelectroencephalogram (EEG) which functions by recording electricalactivity from the scalp. The EEG measures electrical activity producedby the firing of neurons within the brain. In addition, an event-relatedpotential (ERP) measurement may be used. An ERP, for purposes of thisdisclosure is a measured brain response that is time locked to astimulus presented to the subject.

Physiological tests/measurements may be any one of, or a combination of,the following, and are, for purposes of this disclosure, defined asfollows:

Transcranial direct current stimulation (tDCS)—application ofnon-invasive current stimulation via at least one electrode which isalso usable or used for EEG measurements in embodiments of the disclosedtechnology. For purposes of this disclosure, non-invasive currentstimulation also refers to cranial electrotherapy stimulation (CES)which is defined as small pulses of electric current along the head of asubject.

Transcranial magnetic stimulation (TMS)—electromagnetic induction toinduce weak electric currents using a rapidly changing magnetic field tocause activity in specific or general parts of the brain, and used formeasurement of cortical or distance measures of EEG and EMG for evokedresponse latency.

Electromyography (EMG)—measurements of electrical potential of muscles.

Computerized neurophysiological testing (NP)—to estimate a person's peaklevel of cognitive performance. A person's raw score on a test iscompared to a large general population normative sample and/or to thesubjects own baseline measurement.

Force platform or balance plate—a stand-on device usable to determinebalance and/or vestibular dysfunction. The balance plate can collectand/or record balance and/or postural data, such as the center ofpressure and sway movement to analyze vestibular and balance functionunder different test conditions (e.g., unstable foam pad and eyesclosed). The velocity of movement or excursion from balance position canbe quantified for comparison to database norms. For some embodiments,the balance plate can be moved without the need for recalibration, forexample its use in outdoor settings (e.g., sports, military arena).Collected data can be synchronized by software contained in one or morecomputers, with visual input stimuli, EEG, ERP and/or other parametersfor time-locked variance measures associated with brain dysfunction. Forsome embodiments, the balance plate may be operated by way of anelectrical current connection and instructions carried out by way of acomputing device (see FIG. 8) or alternatively with a wirelessconnection between the plate and the computing device for portable use.

Psychological disorder screening—(such as for post-traumatic stressdisorder), a component for vestibulo-ocular reflex dysfunction, acomponent for heart rate variability measures, a component forelectroencephalography measures, and/or a component for transcranialmagnetic stimulation (TMS) delivery with voltage isolator forsimultaneous amplified cortical and distally evoked potential latencymeasures and motor threshold measures.

By way of the above measurements, while non-invasively monitoring EEGreadings of one or multiple sites/regions of the brain, anomalies inneurological impulses are detected. The sites or regions of the brainare then stimulated. As little as one sensor may be used to stimulate,and this anode or cathode may be at the site where the anomaly wasdetected and may be via the same electrode used to locate the anomalyand which measured the anomalous EEG/ERP measurement. Such an electrodemay be in a helmet worn by a user and allows for positive (to increaseneural activity) or negative (to decrease neural activity) stimulationat the site where the anomaly was detected.

Such embodiments of the disclosed technology will become clearer in viewof the following description of the figures.

FIG. 1 shows a high level drawing of a device used to carry outembodiments of the disclosed technology. A helmet 100 comprises at leastone, or a plurality of, electrodes 106 (represented as white dots). Thehelmet may be any receptacle which holds the electrodes in a positionrelative to the head of a wearer, or alternatively, electrodes may betaped or otherwise placed on the head. Earphones 102, goggles 104 and/oranother display device are used in embodiments of the disclosedtechnology to exhibit stimuli to a user, the stimuli used to varymeasurable brain activity. The electrodes 106 are electrically connectedto one of an electrical stimulation device 150 or electrical measuringdevice (e.g., a sensor), such as by way of amplifier 152. The sameelectrode or electrodes may be disconnected from one such device andconnected to another such device, such as by way of changing anelectrical pathway (switch) or by physically disconnecting an electricalwire from one device, and plugging into another. In embodiments of thedisclosed technology, the electrical stimulation and measuring devicesare housed within the same physical device and comprise a switch forchanging the electrical pathway, which is manually operated orcontrolled by pre-programmed instructions. In other embodiments, themeasuring device and stimulation device are in separate housings ordevices, and only one is electrically connected to the electrode orelectrodes 106 at one time. In other embodiments, the electricalstimulation and measuring devices are housed within the same physicaldevise but have separate outlets to which the electrode(s) may beunplugged and attached. Other devices, not shown, include forceplatforms (measure postural deviations of person), devices to alter thedisplay on the goggles 104, and devices to alter the sound through theearphones 102, and input devices such as a computer mouse, keyboards,and joysticks.

Referring now to visual stimuli exhibited on a display device, such asthe goggles 104 of FIG. 1, the visual stimuli produced may be an“immersive environment,” for example a virtual reality 2- or 3-dimensionmoving “room” displayed through a virtual reality headset. The datacollected from the balance plate, heart rate monitor, EEG, and so forth,can be used in conjunction with the visual stimuli forneurophysiological trauma assessment and/or rehabilitation training. Thedata collected from this component, as well as all other components maybe linked with data collected from other components (e.g., EEG, ERP) forassessment purposes.

The system shown in FIG. 1 may further comprise a vestibular activationtest (VAT) headset permitting a computerized test that monitors thevestibulo-ocular reflex (VOR) during natural motion. A VAT headsetuseful for the systems described herein may produce images and/or recordeye movements. Images displayed in the VAT headset may be generated bycomputer-implemented instructions and transmitted via electricalimpulses to the VAT headset via wireless or direct connection. Eyemovements may be recorded by way of the VAT headset. The VOR is a reflexeye movement that stabilizes images on the retina during head movementby producing an eye movement in the direction opposite to head movement,thus preserving the image on the center of the visual field. As oculartrauma is often concomitant with traumatic brain injury, this componentallows additional assessment of injury.

FIG. 2 shows a high level block diagram of a method of carrying outembodiments of the disclosed technology. In step 210, non-invasivemeasurements are made of electrical current in the brain of a testsubject. This is accomplished by way of electrodes placed on a testsubject, such as in a helmet shown in FIG. 1. In this manner, EEG andERP signals may be recorded, measured, and analyzed. A single electrodemay be used to carry out the measuring in step 214, or a plurality ofelectrode pairs may be used in step 212. The position of the electrodesis known, and each electrode or a grouping thereof is placed over adefinable region of the brain, the region defined by a person carryingout embodiments of the disclosed technology. The region is defined as aspecific brain area of interest for the recording, as defined by aperson carrying out embodiments of the disclosed technology and may be aregion covered by a single electrode pair or as large as half ahemisphere of a brain. Electrodes may also be grouped into clusters,such as with a single anode surrounded by three or more cathodes, or asingle cathode surrounded by three or more anodes. Such clusters areelectrically connected, such that electric current flows non-invasivelythrough the proximal tissue from anode(s) to cathode(s), stimulating thebrain (stimulating, herein is defined as passage of electrical currentthrough the brain and includes increasing or decreasing neuron activityat a site).

While conducting step 210, typically, step 220 is also carried out whichcomprises providing sensory stimulus to a person. This may be done byway of, for example, the goggles shown in FIG. 1 for a visualstimulation 222, auditory stimulation 224, balance stimulation 226,biofeedback measurements 228, or other sensory stimulations known in theart. Definitions and examples of various types of such stimulations areprovided above, before the description of the figures. Stress tests andpeak performance tests may also be performed to determine, for example,how many times a minute a person is able to respond to a stimulus, orhow long a person can hold his/her breath or balance on a forceplatform, etc.

Based on the electrical measurements, that is, EEG or ERP measurements,an abnormality in a region of the brain is determined in step 230. Anabnormality may be any of the following: electrical activity which istoo infrequent, too frequent, too low in amplitude, too large inamplitude, an improper pattern of electrical activity,inter-intra-hemispheric connectivity, electrical activity in the wrongportion of the brain for the stimulus given, or the like.

In step 240, based on the located functional abnormality, non-invasivebrain stimulation (such as tDCS) is administered at the region of theabnormality. In certain cases, the same electrode which was used tomeasure the electrical impulses within the brain is used to administertDCS or other electrical stimulation. In this manner, accuracy of thestimulated region may be assured, as there is no difference in thephysical location on the head where the existing electrical impulse wasmeasured, versus where the new electrical stimulation is administered.The place of administering may be as little as a single anode/cathodepair (or cluster), or may use multiple anode/cathode pairs (orclusters).

FIG. 3 shows an example of a test used to measure psychologicalcharacteristics of a test subject. The purpose of at least some of thesetests is to assess the ability of the test subject to automatically andfluently perform relatively easy or over-learned cognitive tasksrelevant to the ability to process information automatically or rapidlyand measure executive function complex decision-making capacity. Tablet310 is a device on which tests can be displayed (visual stimuli), suchas various tests shown in 316. By using an input device, such as stylus312, a user interacts with the visual display to carry out variousfunctions. (The device may be powered via cord 314.) Such tests include,but are not limited to, trails making test, grooved pegboard,symbol-digit test, digit coding, symbol search, Stroop test,finger-tapping tests, categories test, Wonderlic tests and Wechslersubtests, Wisconsin Card Sort Test, matrix reasoning, Raven ProgressiveMatrices tests, and/or components of the neuropsychological assessmentbatteries. Still another type of test is a test of malingering (e.g.,TOMM) which can be part of a comprehensive assessment of both mTBI (mildtraumatic brain injury) and PTSD, as such tests aid in determiningactual impairment resulting from neurophysiologic impairment as opposedto subject feigning or exaggerating. Such tests can assist in minimizingfalse positive mTBI diagnoses. Psychological questionnaires, for examplea set of questions designed to diagnose a particular psychologicaldisorder, such as PTSD, can also be included in computerized or hardcopy form.

An additional component, a single pulse (0.9-1.5 tesla) fixed orvariable Hz setting transcranial magnetic stimulation (TMS) device maybe linked to a voltage isolator with linked amplifier for synchronizedEEG, ERP and/or electromyogram (EMG) recordings. The amplifier (such asamplifier 152 of FIG. 1) may be a multichannel amplifier for multiplemodality physiological measurements (e.g., EMG, ERP, EEG, temperature,blood volume pulse, respiration, skin conductance, EKG, blood pressure,etc.). Sensors for each physiological measurement may also be connectedto the amplifier, for example as a means to collect measurements from atest subject. TMS is a non-invasive technique utilizing magnetic fieldsto create electric currents in discrete brain regions. Typically, duringTMS, a time-pulsed magnetic field is focused on cortical tissue via acoil placed near the area to be affected (e.g., M1, DorsolateralPrefrontal Cortex (DLPFC)). TMS can be utilized for various measurementsof intracortical inhibition and facilitation, for example short intervalintracortical inhibition (SICI), long interval intracortical inhibition(LICI) and contralateral cortical silent period (CSP). Such measurementscan aid in differential diagnosis between individuals with mTBI and mTBIwith PTSD. Any commercially available TMS device known in the art may beutilized. For some embodiments, the TMS device utilized is portable.

FIG. 4 shows a perspective view of a helmet with electrodes used inembodiments of the disclosed technology. FIG. 5 shows a bottom view ofsuch a helmet. The helmet 400 comprises multiple electrodes, such aselectrodes 442, 444, and 446. As can be seen in the figure, a pluralityof electrodes are spaced apart around the interior of a helmet or otherpiece of headgear and are adapted for both reading electrical activityfrom the brain of the wearer and delivering new impulses. That is, byway of a single electrode, plurality thereof, cluster of electrodes, orplurality of clusters, a joint brain electro-analysis and transcranialdirect current stimulation system (tDCS) comprises a plurality ofspaced-apart removable and replaceable electrodes arranged in an item ofheadgear. An electroencephalography device (such as an EEG) is wired toeach of the electrodes, as is a transcranial direct current stimulationdevice (at the same time or alternating by way of a switch orplugging/unplugging a cable between the devices).

A cable 450, which will be discussed at greater length with reference toFIG. 6, allows for electrical connectivity between the electrodes andeither or both of a tDCS and EEG device. Further, a viser 460 isintegrated with the helmet in embodiments of the disclosed technologyfor optical stimulation (e.g. a video monitor).

Upon measuring an electroencephalography anomaly in a brain region withthe electroencephalography device, transcranial direct currentstimulation is engaged to at least one anode and at least one cathodeelectrode to the brain region where said anomaly was measured.Additional devices, as disclosed above, such as a force plate, visualstimuli utilizing interactive games and tests, and the like, may also beutilized. The transcranial direct current stimulation device, inembodiments of the disclosed technology, is engaged only when either a)data from the electroencephalography device indicates that electricalimpulses in the brain are outside a predefined range/threshold of wherethey should be or where is desired by the administrator of the device;and/or b) when the additional physiological characteristic, as measuredwith another device disclosed in the specification herein (such as anEMG device, balance plate, pathological test, etc.) is out of range of apredefined allowable threshold. Thus, the ability to administer tDCS maybe limited by the above factors and, as a safety measure, may be furtherlimited automatically by way of pre-programmed instructions in acomputer device (see FIG. 8) or manually by way of a physician or otherclinical practitioner relying on such data.

Referring further to a force plate (which includes a “balance plate” inembodiments of the disclosed technology), the device is used as follows.The force plate collects (and may record) balance and/or postural data,such as center of pressure, sway movement, and movement velocity toanalyze vestibular and balance function under different test conditions(e.g., unstable foam pad and eyes closed). For some embodiments, thebalance plate may be moved without the need for recalibration, forexample use in outdoor settings (e.g., sports, military arena).Collected data may be synchronized with visual input stimuli,

EEG, ERP and/or other parameters for time locked variance measuresassociate with brain dysfunction. In some instances, visual stimuli areprovided to a subject while the subject utilizes the force plate. Thevisual stimuli produced may be an “immersive environment”, for example avirtual reality 2- or 3-dimension moving “room” displayed through avirtual reality headset. The data collected from the force plate isused, in embodiments of the disclosed technology, for neurophysiologicaltrauma assessment and/or rehabilitation training.

As further seen in FIG. 4, the anodes and cathodes may be in a cluster420 and 440. The clusters shown are by way of example. That is, oneanode (e.g., 444) may be surrounded by three or more cathodes (e.g.,442, 446, and others), or one cathode may be surrounded by three or moreanodes. Anodes and cathodes have opposite polarity, and where neuralactivity is too high in a region, a cathode may be used to suppressactivity. Where neural activity is too low in a region, an anode may beused to increase activity. This may be done between two electrodes, acluster, or a plurality of clusters. In two different regions, it may bedesired, in embodiments of the disclosed technology, to stimulate (orde-stimulate) simultaneously. In this context, “simultaneously” may bedefined as being at the same time or alternating. Different rates ofstimulation at each region may also be used, as necessary. That is, tworegions that should not be linked, in fact are. By firing at differenttimes or rates, in different regions (at the second region, firing from0 to 180 degrees off, in a phase between two firings of the firstelectrode), two synced regions may be brought out of phase. This maynormalize brain activity as regions of the brain require specific phasesimilarities and differences depending upon their relative function.Similarly, by firing at the same time, two out of sync regions may bebrought in phase. Now, the two regions are said to have coherence.Biofeedback (a user viewing his/her own EKG, EEG, ERP, or otherindicators of physiology function) may be utilized in conjunction withthe tDCS, so as to give the user the ability to consciously control hisor her brain or other physiological activity to help the healing processwhen attempting to normalize brain or physiological function (e.g.,heart rate variability) activity.

The electrodes may be separable, so as to be individually placed, or maybe within a sized EEG cap or helmet (such as helmet 100 of FIG. 1). Theelectrodes, which can also be used as anodes and cathodes for purposesof tDCS, may be directly connected to one or more stimulation devices(e.g., tDCS or CES stimulation) and/or measuring devices (e.g., EEGrecording device) simultaneously, or via a switch or removable plug toswitch between such devices. When measuring EEG/ERP readings (electricalimpulses from the brain of a user), various activities (stimuli orphysiological measurements) may take place simultaneously. A fingerdepression device may be used, and others such as a force platform,heart rate monitor, EMG (muscle electric potential), interactivebiofeedback devices allowing the user to monitor internal activity(directly or by way of a game used to control by way of biofeedback),and the like. These measurements may then be compared against a databaseof known human population normative values as indications to determine adeviation from normal function, check the deviation against what isbeing monitored by way of EEG measures and abnormalities of electricimpulses in the brain, and in some embodiments, a correlation may bemade to determine brain abnormalities associated with differentdysfunctions. In other embodiments, the brain abnormalities will serveto verify a particular dysfunction. In still further embodiments, basedon prior determined data of brain electrical abnormalities for aspecific pathology, tDCS or other electrical stimuli (e.g., CES) is theninduced at a region where the brain abnormality is measured.

For example, a database may contain reference EEG components for normaland known pathological results (e.g., IED blast brain trauma, motorvehicle accident brain trauma, Attention Deficit Disorder, Alzheimer'sdisease). In some instances a database may comprise subcategorization ofdata from collected EEG and ERP data. Comparison of subject EEG and ERPresults to such databases can allow for EEG and ERP analysis as part ofthe diagnostic process. Source localization methods (to determinespecific regions of interest and dysfunction) may be accessed forselected EEG and ERP components.

When transcranial direct current stimulation (tDCS) is used as a resultof the above measures, the current may be via the EEG electrodes or canbe delivered by other anode and cathode electrodes (i.e., anode sensorsor cathode sensors placed from a different system) designated for tDCStreatment. For example, sponges may be attached to graphite compositesensor pads sized for anode and/or cathode to ensure proper contact withthe subject. The tDCS device, in embodiments of the disclosedtechnology, directs anodal or cathodal non-invasive brain stimulation toone or more of the connected site locations on the subject. Stimulationcan be delivered as transcranial direct current, or other effectivecurrent type, in amounts between about 0.25 mA and 6.0 mA.

FIG. 6 shows electrical pathways to electrodes within a helmet of anembodiment of the disclosed technology. Electrical connections (such asconnection 470) provide an electrical pathway to and from each electrodeand join at a cable 472 housing all electrical connectors between eachelectrode and an amplifier or other equipment for sending and/orreceiving electrical impulses. Each electrode, such as electrode 446comprises the electrode itself (typically, a metal or other knownconductor, the conductor being removable from an electrode housing 448with disposable electrode boot 449 in embodiments of the disclosedtechnology) with a hole 447 for inserting conductive gel.

FIG. 7 is a side view of an electrode with disposable electrode bootused in an embodiment of the disclosed technology. An encasement 448,such as one made of hard plastic covers the electrode. The electrode 449is attached within the helmet 400. A disposable foam conductive patch isinserted, in embodiments of the disclosed technology, into an electrodesensor. Conductive gel permits a conductive connection from theelectrode, and by extension the foam patch insert, to the skin. Thisconnection permits both the recording of cortical electrical activityand the delivery of anodal or cathodal direct current. Two version ofthis electrode are available: (1) The first version is a soft rubberboot that can be wrapped around a hard plastic electrocap device. Thissoft boot slips onto any of the electrocap sensors and has within it aporous foam or sponge pad. The connective gel that is inserted into theelectrocap hole also flows into this boot as shown in the art. (2) Asecond version is a harder plastic material replacement sensor thatconnects to any wire harness for EEG/ERP and may be built into a helmetor softer cap.

In an embodiment of the disclosed technology, a single interface is usedto control EEG, ERP, and tDCS and is electrically or wirelesslyconnected/engaged with any one of or a plurality of inputs including ECGsensors, a balance plate, a headset, a tDCS cap, or the like. Betweenthe input devices and the interface may be a voltage isolator and/oramplifier. The interface, or a separate computational device (See FIG.8), may be used for data collection and analysis from the EEG/ERP capand other inputs. Visual images may be displayed on a headset and visualand auditory stimuli may be provided by way of a monitor and speakers,respectively.

FIG. 8 is a high-level block diagram of a computational device that maybe used to carry out the disclosed technology. Computer device 800comprises a processor 850 that controls the overall operation of thecomputer by executing the entered program instructions which define suchoperation. The program instructions may be stored in a storage device820 (e.g., magnetic disk, database) and loaded into memory 830 whenexecution of program instructions is desired. Thus, the computer'soperation will be defined by the program instructions stored in memory830 and/or storage 820, and the console will be controlled by processor850 executing the program instructions. A computer 800 also includes oneor a plurality of input network interfaces for communicating with otherdevices via a network (e.g., the Internet). The computer 800 furtherincludes an electrical input interface for receiving power and data froma wired or wireless source. A computer 800 also includes one or moreoutput network interfaces 810 for communicating with other devices.Computer 800 also includes input/output 840 representing devices whichallow for user interaction with a computer (e.g., display, keyboard,mouse, speakers, buttons, stylus, etc.). One skilled in the art willrecognize that an implementation of an actual device will contain othercomponents as well, and that FIG. 8 is a high level representation ofsome of the components of such a device for illustrative purposes. Itshould also be understood by one skilled in the art that the method anddevices depicted in FIGS. 1 through 7 may be implemented on a devicesuch as is shown in FIG. 8.

While the disclosed technology has been taught with specific referenceto the above embodiments, a person having ordinary skill in the art willrecognize that changes can be made in form and detail without departingfrom the spirit and the scope of the disclosed technology. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. All changes that come within the meaning and rangeof equivalency of the claims are to be embraced within their scope.Combinations of any of the methods, systems, and devices describedhereinabove are also contemplated and within the scope of the disclosedtechnology.

1. A bi-directional method of carrying out electrophysiological datarecording and analysis with manual or automated delivery of transcranialcurrent stimulation, comprising the steps of: via at least oneelectrode, providing current stimulation of electrical currents within abrain of a person, the at least one electrode including at least oneanode electrode and at least one cathode electrode, the current of thecurrent stimulation being either direct current or alternating current;via the at least one electrode, conducting a non-invasive measurement ofthe electrical currents within the brain of the person; determiningfunctional abnormality in said person based on said conducting whileproviding directed sensory stimuli to said person; sending anon-invasive brain stimulation via said at least one anode electrode andsaid at least one cathode electrode to said brain of said person; andaugmenting the non-invasive stimulation based on at least one measuredphysiological characteristic of the person.
 2. The method of claim 1,comprising an additional step of conducting non-invasive measurements ofelectrical currents via a plurality of electrode pairs.
 3. The method ofclaim 2, wherein a said electrode pair comprises a cluster of a singleelectrode surrounded by at least three electrodes of opposite polarityto said single electrode.
 4. The method of claim 3, wherein saidnon-invasive brain stimulation comprises sending the non-invasive brainstimulation using a plurality of clusters of electrodes.
 5. The methodof claim 4, wherein all said clusters simultaneously stimulate adifferent region of said brain based on said analysis.
 6. The method ofclaim 4, wherein each said cluster alternately stimulates a differentregion of said brain based on said analysis.
 7. The method of claim 4,wherein said plurality of electrodes is pre-arranged in a single pieceof headgear worn by said person.
 8. The method of claim 1, wherein saidadditional measured physiological characteristic is selected from thegroup consisting of heart rate variability, a measure of neuropathwayspeed and amplitude, a measure of balance, measures of peak performance,and pathology comparisons.
 9. The method of claim 8, wherein a forceplate is used to measure measures of balance.
 10. The method of claim 1,wherein said conducting and said sending are carried out by means of asingle device with a single manually operated control.
 11. The method ofclaim 1, wherein said conducting and said sending are carried out by wayof a pre-configured automated process.
 12. The method of claim 1,wherein said conducting and said sending are carried out by means of twoseparate devices utilizing a single electrical pathway.
 13. The methodof claim 1 further comprising: providing the directed sensory stimuli tothe person in at least one of: an immersive environment and atwo-dimensional interactive screen.
 14. A joint brain electro-analysisand transcranial direct current stimulation (tDCS) system comprising: aplurality of spaced-apart removable and replaceable electrodes orelectrode boots arranged in a piece of headgear, the electrodes orelectrode boots including at least one anode electrode and at least onecathode electrode; an electroencephalography device wired to each ofsaid electrodes; a transcranial direct current stimulation device wiredto each of said electrodes; and an additional device for measuringphysiological characteristics, of a person wearing said piece ofheadgear; wherein, upon measuring an electroencephalographic anomaly ina brain region of the person with said electroencephalography devicewhile providing directed sensory stimuli to the person, transcranialdirect current stimulation is engaged to the at least one anodeelectrode and the at least one cathode electrode of said brain regionwhere said anomaly was measured and such that the non-invasivestimulation is augmented based on at least one measured physiologicalcharacteristic of a person.
 15. The system of claim 14, wherein thedirected sensory stimuli to the person in at least one of: an immersiveenvironment and a two-dimensional interactive screen.
 16. The system ofclaim 14, wherein said at least one anode and said at least one cathodecomprise a cluster of an electrode with a first polarity surrounded byat least three electrodes of a second polarity.
 17. The system of claim16, wherein said cluster is a plurality of clusters, and said currentstimulation is alternated between a first and a second cluster.
 18. Thesystem of claim 17, wherein each said cluster stimulates a differentregion of said brain based on said analysis.
 19. The method of claim 14,wherein said additional measured physiological characteristic isselected from the group consisting of heart rate variability, a measureof neuropathway speed and amplitude, a measure of balance, measures ofpeak performance, and pathology comparisons.
 20. The system of claim 14,wherein said electroencephalography device and said transcranial directcurrent stimulation device are contained within a single housing and areoperable with a single set of controls.
 21. The system of claim 14,wherein switching between use of said electroencephalography device andsaid transcranial direct current stimulation device requires manuallydisconnecting a wire hub between said electrodes and one of said devicesrecited in this claim, and reconnecting said wire hub to the other saiddevice recited in this claim.
 22. The system of claim 19, wherein aforce plate is used to determine measures of balance.
 23. The system ofclaim 22, wherein said force plate is used simultaneously with visualstimuli and an electroencephalography device.